156P - Efficacy and safety of a novel nanosomal docetaxel lipid suspension (NDLS) as an anti cancer agent - a retrospective study

Date 17 December 2016
Event ESMO Asia 2016 Congress
Session Poster lunch
Topics Clinical research
Presenter M Ashraf
Citation Annals of Oncology (2016) 27 (suppl_9): ix46-ix51. 10.1093/annonc/mdw579
Authors M. Ashraf1, R. Sajjad2, M.A. Khan3, M. Shah4, Y. Bhat5, Z.A. Wani5
  • 1Department Of Surgical And Clinical Oncology, Noora Hospital, 190012 - Srinagar/IN
  • 2Department Of Medical Oncology, Noora Hospital, 190012 - Srinagar/IN
  • 3Medical Affairs, Intas Pharmaceuticals Ltd, 380009 - Ahmedabad/IN
  • 4Department Of Internal Medicine And Critical Care, Noora Hospital, 190012 - Srinagar/IN
  • 5Department Of Gastroenterology, Noora Hospital, 190012 - Srinagar/IN

Abstract

Background

The NDLS (DoceAqualip™) is a novel formulation approved in India for various solid tumors. With shorter infusion times without premedication, NDLS has demonstrated good response rates and better tolerability than conventional docetaxel.

Methods

This retrospective study included adult patients with solid tumors (Eastern Cooperative Oncology Group performance status: 0-2) treated with NDLS between June 2014 and June 2016. NDLS was administered as 1-hour IV infusion every 3 weeks at a dose determined by the physician (range: 75-100 mg/m2) based on the tumor type. Endpoints: efficacy as a best overall response rate (ORR, complete response [CR] + partial response [PR]), disease control rate (DCR, CR + PR + stable disease [SD]) evaluated using CT, MRI, USG, Tumor Marker or Status, and safety (incidence of adverse events [AEs] with toxicity grades).

Results

Among 69 patients analyzed, 37 (54%) were men (mean age: 55.2 ±14.9 years). Majority had cancer stage III (54%) and IV (36%). Gastric adenocarcinoma was the most common (35%), followed by ovarian cancer (20%), and non-small cell lung cancer (19%). NDLS was administered in metastatic (42%) or neo-adjuvant (36%) setting. Of 56 patients evaluable for response, the best ORR was achieved in 33 (59%) patients (CR: 7 [13%], PR: 26 [46%], p 

Conclusions

The NDLS demonstrated a promising overall response and was well-tolerated following multiple doses (75-100 mg/m2) in patients with different solid tumors in advanced disease setting.

Clinical trial indentification

Legal entity responsible for the study

N/A

Funding

Intas Pharmaceuticals Ltd., India

Disclosure

All authors have declared no conflicts of interest.